Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants

Kamath, Veena G and Kulkarni, Muralidhar M and Hegde, Asha P and Nayak, Dinesh M (2019) Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine, 37 (19). pp. 2554-2560. ISSN 0264-410X

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Abstract

Background: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil and for lot-to-lot consistency. Methods: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards. Results: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRVPV to Rotasiil� was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil group was causally related.

Item Type: Article
Uncontrolled Keywords: Liquid Bovine-Human reassortant; pentavalent rotavirus vaccine (LBRV-PV); Lot-to-lot consistency; immunogenicity; safety.
Subjects: Medicine > KMC Manipal > Community Medicine
Medicine > KMC Manipal > Paediatrics
Depositing User: KMC Library
Date Deposited: 24 May 2019 03:48
Last Modified: 24 May 2019 03:48
URI: http://eprints.manipal.edu/id/eprint/153830

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